A first in CAR-T cell therapy: KYMRIAH now approved for R/R DLBCL and paediatric/young adult B-cell ALL1
KYMRIAH is indicated for the treatment of:
- Paediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post transplant or in second or later relapse
- Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy
of sustained efficacy:
KYMRIAH delivers lasting high response rates where other therapies have failed1
KYMRIAH uses a CAR construct that contains the 4-1BB costimulatory domain to enhance early T-cell expansion and long-term persistence1
Novartis has developed a rigorous process to reliably and accurately deliver KYMRIAH, an individualised treatment, on a global scale
KYMRIAH gives physicians and patients the flexibility of cryopreservation and the potential for a convenient outpatient experience1
FINDING QUALIFIED TREATMENT CENTERS*
*Not all centers will treat for both KYMRIAH indications.
transforming the treatment of
Only KYMRIAH uses a CAR construct that contains the 4-1BB costimulatory domain1
- An autologous, adoptive immunocellular therapy, KYMRIAH reprograms a patient's own T-cells to express a CAR that targets malignant (and other) B-cells
- Specifically designed to enhance early T-cell expansion and long-term persistence of CAR-T cells
Lentiviral transduction delivers transgene encoding the CD19-specific CAR1
The KYMRIAH CAR-T cell therapy includes the CD19 antigen binding domain, a 4-1BB costimulatory domain, and a CD3Î¶ signalling domain. The 4-1BB costimulatory domain is designed to enhance early T-cell expansion and long-term persistence of CAR-T cells1-3
KYMRIAH CAR-T cells have the ability to bind to and eliminate CD19-expressing malignant and other B-cells1
Collaboration drives the creation of this transformative treatment
Partnership between the primary haematologist/oncologist and the KYMRIAH Treatment Center is crucial to the treatment process.
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Manufacturing: Our success comes from our commitment to quality
Proven Process on a Global Scale
KYMRIAH has been studied in global clinical trials in 11 countries and 27 sites across Europe, United States, Canada, Australia, and Asia.5 Because of these trials, Novartis has demonstrated its ability to deliver KYMRIAH on a global scale.
Manufacturing Success Rate
Novartis had a high success rate in manufacturing KYMRIAH for patients in the pALL and DLBCL pivotal trials of our global clinical trial program.1
The Novartis manufacturing process was designed to return the highest quality product to patients in a timely manner with a target end-to-end turnaround time of 25-28 calendar days.
Manufacturing KYMRIAH utilizes cryopreservation of immune cells, allowing greater flexibility for patients.1 Cryopreservation also extends storage for up to 30 months and ensures reliable shipping of leukapheresis material.